We work with partners and stakeholders in a number of ways to make improvements to different areas of the research process. These projects and collaborations complement other projects undertaken solely by the HRA.
Our Collaboration & Development Forum brings together a range of organisations that have a role in improving the environment for research, and meets quarterly. The minutes from the latest meeting of the Forum are available here, and the most recent update from its members here. To keep up to date with our projects, please subscribe to our bimonthly newsletter, HRA Latest.
These are our current work areas:
- Technical Assurances
- Complex Applications
- Working with funders
- Site/researcher competency
We have identified issues with some studies arising from variable oversight by some non-commercial sponsors, particularly for studies other than clinical trials. Led by non-commercial sponsors, we are supporting the development of a toolkit for sponsors, developing training for sponsor staff and improving escalation routes when issues arise. The Collaboration and Development Forum has established a reference group for non-commercial sponsors (link to ToR) which met for the first time in September 2014.
In February 2013 the HRA ran a stakeholder event which included a series of workshops to collate feedback on a range of collaborative workstreams, including Sponsorship Standards. As part of the output from this a consultation on sponsors responsibilities was held in 2014 as a result we have released our expectations of sponsors.
The roles and responsibilities of sponsors, including detailed information on responsibilities specifically in relation to HRA Approval, can be found here.
We have become aware that the quality and content of protocols received by the HRA and other reviewers is highly variable. Strong feedback highlighted considerable variability of content and sometimes poor quality of protocols is causing delays to reviews. In response to this we have facilitated work to develop guidance to assist organisations and individuals to improve the consistency and quality of their protocols.
Working groups of relevant experts from a wide range of organisations were convened in order to share best practice, supply content and comment on drafts of the template and guidance. These organisations were identified via existing Collaboration & Development networks and calls for volunteers. The output of these groups led to two consultations in 2015 one for CTIMPs and one for Qualitative Research which resulted in the development of protocol guidance for these research types which will be released as part of our Learning Resources later in 2016.
These learning resources are designed to:
- Provide guidance and walk people through the process of preparing a protocol for HRA Approval and other reviews.
- Support educational providers who train novice researchers.
- Improve the consistency and quality of protocol especially in qualitative research where we are aware of a large viability in quality.
- Contain of the point on the SPIRIT checklist giving assurance that protocols are in line with SPIRIT.
We continue to work with the EQUATOR Network on producing protocol guidance for other study types to align with current and future initiatives to improve the quality, reliability and value of medical research.
3. Technical Assurances
What are Technical Assurances?
Technical Assurance is the coordinated clinical assurance process for studies that involve Pharmacy (CTIMPS) and/or Ionising Radiation.
There are two types of Technical Assurances – Pharmacy Assurance and Radiation Assurance.
Pharmacy Assurance involves the conduct of a single technical pharmacy review of studies where pharmacy departments at participating sites will be involved in setting up and running aspects of a trial. You can find out more about it here.
Radiation Assurance involves the management of the Clinical Radiation Expert (CRE) and Medical Physics Expert (MPE) reviews required in Part B Section 3 of the Integrated Research Application System (IRAS) form when research exposures to ionising radiation are involved in a study. You can find out more about it here.
In future the Health Research Authority (HRA) will be implementing a standard review fee for new studies of £500 per review, for each Reviewer required. These fees have been classified as a Part A research cost and are exclusive of VAT. Announcements will be made once our guidance has been finalised and an implementation date for the new charges is agreed. We are advising applicants who are currently seeking funding to include the cost in their grant applications in anticipation of this being implemented.
You can see the current arrangements for payment in the information about each Assurance.
4. Complex Applications
Large multicentre studies and projects in hard to recruit populations e.g. rare diseases are sometimes complex to set up and recruit to in the NHS. Complexity can be due to the regulation of activity and/or the logistics of setting-up projects across primary, secondary and social care. HRA Approval has streamlined the set-up of studies across the NHS. For infrastructure projects that do not require HRA Approval (Bioresourses, databases) work is being undertaken on streamlining necessary approvals and governance arrangements to allow easy set-up and flow of material across the NHS. We are developing proposals to address specific issues faced by those working in particular research areas: rare diseases, bioresources, and regenerative medicine.
Establishing what parts of programmes or large projects are research or not will influence which regulatory and governance pathways to follow to allow smooth setup in the NHS. The HRA are working with a number of stakeholders (both commercial and non-commercial) to build confidence in what activities constitute research quick and consistent setup of programmes across the NHS. Advice on projects can be sought via the HRA Queries line.
5. Working with funders
We are working with research funders to identify how to improve the quality of research summaries. These provide information for reviewers, researchers, potential participants and the public about research projects. We want to standardise the requirements to avoid duplication in providing different summaries for different purposes. The HRA publishes the summaries submitted as part of the application for ethical review. During 2016 we will be looking beyond the approvals process to consider how to streamline progress reporting requirements and cost attribution across the whole research pathway.
We have recently worked in conjunction with NIHR funders and DH to bring about changes to the standard DH contract for research, meaning studies can be set up more promptly in more cases, and patient benefit achieved more quickly. More information can be found here.
6. Site/researcher competency
We issued a joint statement with MHRA in July 2012 on Good Clinical Practice training. We continue to encourage providers to ensure training is appropriate to different types of research and to the research activities and roles that individuals will undertake. We feel there is still a need for more training to be tailored specifically to meet the needs of those conducting research in the NHS other than clinical trials. There have been demands from some companies for better ways to assess whether researchers and sites are competent to conduct a particular study. We have been linking with collaborations in the UK and internationally to assess the potential of voluntary accreditation for sites and for researchers, and whether this would improve the quality of research and improve the set-up and delivery of projects.
Throughout 2016 and beyond we will be looking at ways in which we, researchers, funders and other regulators can build on more proportionate approaches to setting up and undertaking research in the UK. We anticipate that this will inform the discussions of HRA’s Board with regard to our strategic direction, as well as the decision makers within our stakeholders.
In addition to identifying opportunities, we are working with the community to understand what proportionality in research means to different stakeholders by using existing opportunities for discussions as well as ad hoc conversations.
In 2014 we had a team of Application Managers to support specific aspects of the research review process. They provided advice to researchers and sponsors of complex or ‘at-risk’ studies in navigating the approvals process. Learning for these situations, the resolutions for individual cases informed HRA policy and operational guidance relating to HRA Approval and their function has been written into HRA Assessors job descriptions.
In 2014, a harmonised UK-wide process for handling amendments for NHS R&D was introduced. This new system introduces a system of categorisation and presumed implementation. The HRA is responsible for managing this process for amendments for all studies, where the lead site is in England. As of 31st March 2016 this process forms part of HRA Approval. Details of the process and related guidance can be found here.